Bipolar DisorderNCT01678989
Evaluation of Brain MRI and Clinical Characteristics of Adolescents With Bipolar Disorder and Children of Parents With Bipolar Disorder
An observational study of Bipolar Disorder, run by Turkish Psychiatry Association at 1 site in Turkey (Türkiye).
Trial summary
Genetic transition is important in the etiology of bipolar disorder (BD). So, evaluation of children of BD parents and diagnosed with and BD children whether or not brain has affected zones. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2011to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: In this study, the cranial MRI findings and clinical features in adolescents with bipolar disorder and the same age and sex matched children who have parents with BD and healthy controls were investigated.
Who may be able to join
- Children with BD between the ages of 12-18
- Parents with BD who have children between the ages of 12-18
- Healthy children whose parents do not have BD
- Patients who does not have mental or organic disability to answer the questions
- Graduated from primary school
Who cannot join
- Patients who have mental or organic disability to answer the questions
- Patients who have a history of any chronic disease which is likely to affect the central nervous system
- Patients who have a contraindication for any first application for Magnetic Resonance Imaging (MRI)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ondokuz Mayis University Medical Faculty Department of Child and Adolescent Psychiatry
Samsun, 55139
Seher Akbas, 00903623121919 ext. 3128, akbasseher@hotmail.com
Seher Akbas
About this study
Genetic transition is important in the etiology of bipolar disorder (BD). So, evaluation of children of BD parents and diagnosed with and BD children whether or not brain has affected zones. These groups were compared to healthy controls and whether or not the mental health of children is influenced will be evaluated by the clinical investigation.
Read the detailed description
MRI studies in children at risk of BD, our understanding of the neurobiology of BD and abnormalities in the studied regions, regions that predispose to the development of our understanding of PBB will shed light on the etiology of the disorder. In this study, the cranial MRI findings and clinical features in adolescents with bipolar disorder and the same age and sex matched children who have parents with BD and healthy controls were investigated. Since there is few studies that evaluate these three groups, there is a need to increase our knowledge on this issue.
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar disorder, Children, Cranial MRI
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient group | Children with BD, (20 children) 12-18 year-old who agreed to participate in the study will be established. | |
| Risk group | Twenty healthy children of 12-18 years old who have mothers and/or fathers who previously assessed by an adult psychiatrist and diagnosed as BD according to DSM-IV diagnostic criteria, and who agreed to participate in the study. The age and gender of the groups will be matched. | |
| Healthy control group | Twenty participants between the ages of 12-18 who agree to participate in the study and whose family members do not have BD. The age and the gender of the groups will be matched. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2012 (estimated)
- Study startJul 2011
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turkish Psychiatry Association
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seher Akbas, Turkish Psychiatry Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01678989
- Sponsor's protocol ID
- 4946498
- Status last verified
- Aug 2012
- First submitted
- 31 Aug 2012
- Last updated
- 5 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Brain MRI and Clinical Characteristics of Adolescents With Bipolar Disorder and Children of Parents With Bipolar Disorder
- ClinicalTrials.gov ID
- NCT01678989
- Acronym / sponsor ID
- 4946498
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar disorder, Children, Cranial MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Turkish Psychiatry AssociationUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 5 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Genetic transition is important in the etiology of bipolar disorder (BD). So, evaluation of children of BD parents and diagnosed with and BD children whether or not brain has affected zones. These groups were compared to healthy controls and whether or not the mental health of children is influenced will be evaluated by the clinical investigation.
Detailed description
MRI studies in children at risk of BD, our understanding of the neurobiology of BD and abnormalities in the studied regions, regions that predispose to the development of our understanding of PBB will shed light on the etiology of the disorder. In this study, the cranial MRI findings and clinical features in adolescents with bipolar disorder and the same age and sex matched children who have parents with BD and healthy controls were investigated. Since there is few studies that evaluate these three groups, there is a need to increase our knowledge on this issue.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient group | – | –Children with BD, (20 children) 12-18 year-old who agreed to participate in the study will be established. |
| Risk group | – | –Twenty healthy children of 12-18 years old who have mothers and/or fathers who previously assessed by an adult psychiatrist and diagnosed as BD according to DSM-IV diagnostic criteria, and who agreed to participate in the study. The age and gender of the groups will be matched. |
| Healthy control group | – | –Twenty participants between the ages of 12-18 who agree to participate in the study and whose family members do not have BD. The age and the gender of the groups will be matched. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- In this study, the cranial MRI findings and clinical features in adolescents with bipolar disorder and the same age and sex matched children who have parents with BD and healthy controls were investigated.
Key inclusion criteria (5 listed)
- Children with BD between the ages of 12-18
- Parents with BD who have children between the ages of 12-18
- Healthy children whose parents do not have BD
- Patients who does not have mental or organic disability to answer the questions
- Graduated from primary school
Key exclusion criteria (3 listed)
- Patients who have mental or organic disability to answer the questions
- Patients who have a history of any chronic disease which is likely to affect the central nervous system
- Patients who have a contraindication for any first application for Magnetic Resonance Imaging (MRI)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by Turkish Psychiatry Association at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seher Akbas (09003623121919 ext. 3128, akbasseher@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2012.